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U.S. Department of Health and Human Services

Class 2 Device Recall DIGIT TRAP FINGER GRASPING DEVICE

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  Class 2 Device Recall DIGIT TRAP FINGER GRASPING DEVICE see related information
Date Initiated by Firm January 28, 2010
Date Posted August 24, 2010
Recall Status1 Terminated 3 on December 15, 2010
Recall Number Z-2250-2010
Recall Event ID 54701
Product Classification Disposable Surgical Instrument - Product Code KDC
Product REF 9906, DIGIT TRAP FINGER GRASPING DEVICE, STERILE.

CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

Intended for use in small joint arthroscopic procedures.
Code Information Lot Number: 46718 27646 27651 46723 46721 46725 65281 65282 65286 65287 65285 65288 65284 65289 65283 65290 79999 72402 80005 72400 72387 72397 80002 72396 82263 80084 80083 80004 80001 82269 82268 82267 82264 80085 80086 80087 82260 83464 83356 83466 82271 83354 83351 83463 83465 83359 83358 83475 83473 83474 83476 83477 83470 82266 83469 83468 83467 83472 83471 82270 91993 89393 87332 89395 87330 87329 87328 87331 89392 91991 89394 91990 91989 89391 91994 91992 91996 91997 91995 94244 94242 95864 95865 94247 95866 95863 95860 94248 94246 95861 94245 95862 97811 97809 97812 97808 97810 95868 95858 95869 97814 100148 100151 100152 100150 100153 100147 97813 100149 105175 102411 102412 102414 102415 82272 105353 102416 102417 106093 106095 106092 105356 106094 106979 106978 106977 105355 107307 107308 107306 109531 107305 107309 109533 109534 107304 107302 107303 113326 116073 116072 116071 116070 116069 115111 115110 113324 117756 117755 119290 119289 119291 119292 119293 119294 121908 121909 121910 121915 123605 123601 121911 123603, and  121914. 
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-392-6464
Manufacturer Reason
for Recall		 This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents.
FDA Determined
Cause 2		 Material/Component Contamination
Action Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
Quantity in Commerce 35,451 total
Distribution Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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